Beclomethasone dipropionate, a diester of beclomethasone, is a corticosteroid used as an antiallergic, antiasthmatic and topical anti-inflammatory. It is primarily used in nasal inhalers to relieve symptoms of nasal inflammation and irritation often associated with allergies, and in oral inhalers to treat symptoms of bronchial asthma.
Beclomethasone dipropionate has also been used to treat oral inflammatory disease. When treating inflammatory conditions of the mouth by administering beclomethasone dipropionate into the oral cavity, a number of conditions are present that make it difficult to effectively deliver a therapeutically effective amount for a prolonged period of time (e.g., for periods greater than several minutes). For example, when a patient applies a spray to the oral cavity, the therapeutic level of the drug exists for only a short time period. Additionally, when a patient is given a drug-containing lozenge or lollipop, there is a natural tendency to suck and chew on it thereby effectively reducing the time period during which the drug can be buccally administered by the lozenge. In addition, the action of saliva and swallowing by the patient effectively reduces the concentration of drug along the buccal membranes of the oral cavity and further causes much of the drug to be swallowed. This has been a particular problem in treating inflammatory diseases of the mouth which require constant local administration of beclomethasone dipropionate.
U.S. Pat. No. 4,863,737 describes the delivery of beclomethasone dipropionate by lollipop. As discussed above, this method of delivery is effective only for a short time period. Moreover, the patent is directed to treatment of disease by systemic delivery of beclomethasone dipropionate, rather than local treatment of inflammatory disease of the oral cavity. Accordingly, the patient is subject to the side-effects of systemic delivery of beclomethasone.
U.S. Pat. Nos. 4,835,142 and 4,294,829 and EP 0 391 342 describe the delivery of beclomethasone dipropionate by powdery and gel base sprays. Unfortunately, when a drug is administered by a spray, the drug is released at a therapeutic level for a very short period of time. Accordingly, this dosage form requires frequent repetitive dosing in order to effectively treat inflammatory disease.
U.S. Pat. No. 4,765,983 describes the delivery of beclomethasone dipropionate to the oral cavity of a patient by medical adhesive tape. Tape has a tendency to cause irritation to the patient and, accordingly, is not desirable from the standpoint of patient comfort. Moreover, since the device is adhered to the buccal membrane and maintains a high concentration of the drug at a single membrane site, the beclomethasone dipropionate is delivered systemically with the resulting side-effects. Additionally, it is difficult to treat numerous areas in the mouth using tape.
Thus, there has been a need in the art for a method of treating oral inflammatory diseases, such as stomatitis, erosion or sores, that is able to continuously locally deliver beclomethasone dipropionate for extended periods of time to the oral cavity.